Home › Fresenius Kabi AG › AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike
AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike
Fresenius Kabi AG · Model 4R2358 · UDI-DI 00810020440270
GKT
Prescription
10
510(k) clearances
6,581
Adverse events (266 deaths)
1
Recalls
39
Facilities
Description
For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-25 | Fenwal Inc | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.